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Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia

BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00511628
Enrollment
1717
Registered
2007-08-06
Start date
2001-07-31
Completion date
2003-01-31
Last updated
2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

Schizophrenia, Risperidone, Schizoaffective disorder, Schizophreniform disorder, Weight gain

Brief summary

The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

Detailed description

This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) \>25, or for patients that have increased their body weight \>7% in the last year with the previous treatment (even with a BMI\< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I & II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).

Interventions

DRUGRisperidone

As prescribed

Sponsors

Janssen-Cilag, S.A.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI \>25 * Patients have increased their body weight \>7% in the last year with the previous treatment even with a BMI\< 25 * Patients that have shown intolerance to a previous antipsychotic treatment

Exclusion criteria

* Pregnant or lactating patients * Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder * Patients with neurology pathology except Parkinsonism induced by neuroleptics * Patients with other severe concomitant pathology * Patients treated with Risperidone in the last 30 days.

Design outcomes

Primary

MeasureTime frame
Safety Evaluation of Risperidone in patients who are overweight and/or obese6 months

Secondary

MeasureTime frame
Effectiveness6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026